Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.
|In the eyes of the FDA and other regulatory
bodies, inadequate documentation is unacceptable.
Planning is Essential
According to Santos-Serrao, a central component of developing a process validation strategy is the identification of the essential processes that must be validated in the early stages of the product lifecycle. This allows a manufacturer to focus documentation on its most essential areas and, subsequently, makes it easier to refine process validation efforts. It is not a requirement for a manufacturer’s formal strategy to be included in a validation master plan (VMP), but Santos-Serrao states that best practices stress the importance of 1) outlining a plan for processes that will need to be validated and 2) documenting all the decisions made along the way.
While process validation strategies vary dramatically from one company to another, Santos-Serrao recommends that all companies should consider the implementation of a lifecycle approach, meaning that planning should commence in the earliest stages and be continually reevaluated throughout a product’s entire lifecycle.
Documentation Should be a Business Accelerator, Not a Burden
In the eyes of the FDA and other regulatory bodies, inadequate documentation is unacceptable. Because documentation is so vital to process validation, manufacturers are best prepared if they’ve implemented an electronic document management system (EDMS) that can facilitate effective management of the massive amount of information that needs to be maintained and tracked, even starting from the most preliminary stages when the product is just a seed of an idea. According to Santos-Serrao, a good EDMS should have sufficient functionality to effectively handle:
- document control,
- document revision control,
- complex document lifecycles, and
The Bottom Line
Santos-Serrao comes to the conclusion that there a common thread through all pertinent regulatory guidelines: process validation is a science-based and risk-based approach to continuous improvement throughout each stage of a product’s lifecycle. While there are a variety of methods for generating and maintaining documentation, she states that an automated document management system is the best way to expedite process validation activities, avoid costly mistakes, and decrease wasted hours and re-work. A good system benefits everyone from the highest executive to the part-time lab worker and everyone in between. Ultimately, an EDMS gets a company’s product on the market much sooner than it otherwise would without one.
You can read Santos-Serrao’s complete article on pharmtech.com here.
James Jardine is a marketing communications specialist for MasterControl Inc. He has a bachelor’s degree in journalism from the University of Utah and is based in MasterControl’s headquarters in Salt Lake City, Utah.
Patricia Santos-Serrao is a senior product manager at MasterControl with nearly two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.
Prior to joining MasterControl, Santos-Serrao was the manager of global regulatory solutions for QUMAS, where she helped drive the development, sales, marketing and implementation of solutions for pharmaceutical R&D, with a particular focus on submission document management. She has worked for several Tier-1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim. She has also assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs and other submission format filings worldwide.
Santos-Serrao earned her bachelor’s degree in business administration at Western Connecticut State University and University of Phoenix. She has earned her Regulatory Affairs Certification (RAC) from RAPS and the Regulatory Affairs Certification Board (RACB). She is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA).